An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence

NCT00080470 | Completed Phase 3 Results

• 1 other identifier: CR-B-001
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 11

Brief Summary

This clinical trial is being conducted to investigate the safety and effectiveness of a new device designed to treat urinary urge incontinence in those patients who have tried and failed two or more conservative therapies.

Conditions

Urinary Incontinence

Keywords

Incontinence; Refractory; Urinary; Urge; Stimulation; Nerve; Microstimulator; Neuromodulation

Outcome Measures

Primary Outcomes (2)

• Number of Leaks Per Day

  12 months

• Freedom From Major Complications

  5 years

Study Arms (2)

1

EXPERIMENTAL

Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.

Device: bion

2

SHAM COMPARATOR

No Stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.

Device: bion

Interventions

bion DEVICE

battery powered microstimulator

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years and above.
• Diagnosed with urinary urge incontinence.
• Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor.
• Have normal upper urinary tract function.
• Be capable of giving informed consent.
• Be capable and willing to follow all study related procedures.

You may not qualify if:

• Have any active implantable device regardless of whether stimulation status is ON or OFF.
• Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period.
• Less than one year post partum and/or are breast-feeding.
• Have any passive implant that contains metal or electrically conductive materials.
• Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.
• Have conditions requiring diathermy procedures.
• Have an inability to operate the bion Remote Control and bion Recharging System either by self or caregiver.
• Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.
• Have history of coagulopathy or bleeding disorder.
• Have a history of pelvic pain as primary diagnosis.
• Have anatomical restrictions such that the study device placement is not possible.
• Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function.
• Have a life expectancy of less than 1 year.
• Cannot independently comprehend and complete the QoL questionnaires.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (11)

Arizona Health Sciences Center (University of Arizona)

Tucson, Arizona, 85724, United States

Location

The Department of Urology, Stanford University Medical Center

Stanford, California, 94305-5118, United States

Location

Milestone Medical Research

Englewood, Colorado, 80112, United States

Location

Bladder Control Center of Norwalk

Norwalk, Connecticut, 06850, United States

Location

Walter Reed Army Medical Center, Division of Pelvic Medicine and Reconstructive Surgery

Washington D.C., District of Columbia, 20307-5001, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Cornerstone Medical Specialty Center

Woodbury, Minnesota, 55125, United States

Location

The Pelvic and Sexual Health Institute (affiliated with Graduate Hospital)

Philadelphia, Pennsylvania, 19146, United States

Location

Dallas Center for Pelvic Medicine

Dallas, Texas, 75231, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Sound Urological Associates

Edmonds, Washington, 98026, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was limited by poor adherence to the clinical protocol and by incomplete data recovery. Analysis of efficacy-related endpoints was not possible.

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Boston Scientific

Valerie.Lucero-Cimmarust@bsci.com

866-360-4747

Study Officials

• Tamara Baynham, PhD

  Boston Scientific, Neuromodulation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2004
• First Posted: April 5, 2004
• Study Start: June 1, 2003
• Primary Completion: July 1, 2008
• Study Completion: December 1, 2012
• Last Updated: November 19, 2013
• Results First Posted: October 10, 2013

Record last verified: 2013-10

Locations

US (11)